REGULATORY UPDATE: FDA Determines Zika Virus Testing is No Longer Necessary

May 12, 2021

The Food and Drug Administration has withdrawn its July 2018 Zika virus (ZIKV) testing guidance, stating that “testing for ZIKV, or pathogen reduction as an alternative to testing for ZIKV, is not necessary to comply with the requirements of 21 CFR 610.40(a)(3).” The agency determined that ZIKV is no longer a relevant transfusion-transmitted infection (RTTI) under FDA’s regulations because the virus no longer has sufficient incidence and/or prevalence to affect the potential donor population. AABB applauds the agency’s decision and has long supported this evidence-based approach to updating the ZIKV testing policy.

The agency provided detailed information on the basis for this decision. FDA also provided this important reminder for centers discontinuing ZIKV testing: “Licensed blood establishments that discontinue testing must report the change to FDA in their annual report under 21 CFR 601.12(d), noting the date testing was discontinued. Corresponding changes to the circular of information must also be reported in the annual report under 21 CFR 601.12(d).”

To assist centers in updating their Circular of Information for the Use of Human Blood and Blood Components, AABB will post a statement on the Circular web page that may be added on the blank pages at the front of the Circular. AABB will publish this information by Friday, May 14. Corresponding changes to the Circular must also be reported in the annual report under 21 CFR 601.12(d). 

In 2016, AABB initiated the AABB ZIKV Biovigilance Program in response to the FDA’s first ZIKV guidance and deployed an enhanced ZIKV reporting platform in December 2018 to support FDA’s July 2018 ZIKV guidance. AABB would like to thank all the participating blood collection establishments for contributing data to the platform. These data are regularly referenced by regulatory bodies and researchers. 

AABB will inform members centers on the platform decommissioning process via future communication.